לוח משרות דרושים מהנדס איכות בחיפה וסביבתה

Requirements:
Bachelor degree in mechanical, industrial or similar engineering disciplines.
3+ Years of Quality Assurance experience in Medical device companies or other highly regulated industries.
Strong written and verbal communication skills (English and Hebrew)
Strong knowledge of applicable standards and regulations standards (FDA, ISO13485, MDD).
Auditing experience.
Nice to Haves
Strong understanding of process validation principles, including experience with master validation plans, installation qualifications, operational qualifications, process qualifications, and test method validations.
Vast experience with design changes, change impact assessment and design transfer activities.
Certified Quality Engineer (CQE) or other similar Quality/reilibility certifications.
Six Sigma certification.

Requirements:
At least 5 years of experience as a QMS Specialist/Eng./Manager
Bachelors degree in a relevant field, such as Engineering, Computer science, etc.
Strong knowledge of quality management principles specific to the medical device industry, including ISO 13485:2016, FDA QSR, and EU MDR (an advantage) experience with Multidisciplinary products or SaMD (an advantage).
Familiar with cybersecurity and privacy standards and regulations, such as ISO 27001:2013 an advantage
Experience working in a software company, with a dynamic environment
Certified Quality Engineer (CQE / CQM) an advantage
Certified Internal Auditor an advantage
Proven track record of communicating effectively in English, both orally and written.
Previous experience in implementing and maintaining a QMS in the medical device industry, with a solid understanding of medical device regulations and standards.
Familiarity with applicable regulatory requirements and standards, such as ISO 14971 and IEC 62304.
Strong analytical and problem-solving skills
Attention to detail and a commitment to maintaining high-quality standards
Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.

Requirements:
Ensure the proper implementation of the SDLC process according to IEC 62304, the quality of the documentation (review and approval ) in the project, that is compliance with the regulatory requirements
Support SW production/release documentation and ECO
Provide Quality support at various stages of Product Development and coaches others in analysis and decision making
Ensuring that R&D procedures and work instructions are continuously up-to-date and effective
Lead Risk Management processes according to ISO 14971
Provides the quality/independent review at defined design reviews and project design plans, for new development projects as well as design/process changes
Support the implementation of eQMS systems and quality tools used in the development process, including documentation, testing, and monitoring of the product
Keeps up to date on all ISO/FDA/MDR and other Product Development related regulatory requirements and relays this information to the Product Development group
Qualifications:
Bachelors degree in Engineering or related field, such as Engineering, Computer science, etc
5 years of related experience in the medical device, experience with the development of Multidisciplinary products or SaMD
Expert understanding of appropriate global medical device regulations, requirements, and standards, including Quality Management System ISO 13485/ QSR / MDR, SDLC IEC 62304, and Risk Management ISO 14971
Familiar with cybersecurity and privacy standards and regulations, such as ISO 27001:2013 an advantage
At least 5 years of experience as a QMS Specialist/Manager
Certified Quality Engineer (CQE / CQM) an advantage
Certified Internal Auditor an advantage
Project Management (development of project plans, status meetings, project reporting, etc) and organizational change movement
Ability to communicate perfectly in English both orally and in writing
Self-motivated and able to manage time working on multiple projects simultaneously
Tech Savvy Demonstrated competency in computer skills
Must be able to communicate appropriately and adequately to all management levels